The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

November 18, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

The Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection in Human Epidermal Growth Factor Receptor 2 (HER2) Negative Recurrent/Metastatic Breast Cancer

This study aims to evaluate the efficacy and safety of TQB2102 for injection in HER2 negative recurrent/metastatic breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bozhou, Anhui, China, 236804
        • Not yet recruiting
        • Bozhou People's Hospital
        • Contact:
      • Chuzhou, Anhui, China, 239001
        • Not yet recruiting
        • Chuzhou First People's Hospital
        • Contact:
      • Hefei, Anhui, China, 230031
        • Not yet recruiting
        • Anhui Provincial Public Health Clinical Center
        • Contact:
      • Ma'anshan, Anhui, China, 243000
        • Not yet recruiting
        • Ma'anshan People's Hospital
        • Contact:
      • Wuhu, Anhui, China, 241399
        • Not yet recruiting
        • Wuhu Hospital Affiliated to East China Normal University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • The Third People's Hospital of Zhengzhou
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • The first People's Hospital of Zhengzhou
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
    • Hunan
      • Changde, Hunan, China, 415003
        • Not yet recruiting
        • The First People's Hospital of Changde City
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital ,Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • Not yet recruiting
        • Cancer Hospital affiliated to Xinjiang Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
      • Suzhou, Zhejiang, China, 234099
        • Not yet recruiting
        • Suzhou Municipal Hospital
        • Contact:
          • Xiyong Wang, Doctor
          • Phone Number: 19805571600
          • Email: xy9026@qq.com
      • Wenzhou, Zhejiang, China, 325015
        • Not yet recruiting
        • Wenzhou Medical University Affiliated First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The participants voluntarily participate in the study and sign an informed consent form.
  • Age: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) score: ≤1 point; Expected survival period exceeds 3 months.
  • Breast cancer patients diagnosed as HER2 negative by pathology, with evidence of local recurrence or distant metastasis are not suitable for surgery or radiation therapy aimed at healing.
  • Sufficient tumor tissue samples must be available for HER2 evaluation by pathologists at the main research center.
  • The participants's previous treatment needs to meet the following criteria: failure after receiving at least first-line systemic chemotherapy during the recurrence /metastasis stage (for hormone receptor positive participants, failure after receiving cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors combined with endocrine therapy during the recurrence/metastasis stage.
  • There exists disease progression or intolerance during or after the most recent treatment before enrollment.
  • According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, there should be at least one measurable lesion.
  • The main organ functions well and meets certain standards.
  • Female participants of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; within 7 days prior to enrollment, the serum pregnancy test was negative and must be a non lactating subject; male participants should agree to adopt avoidance measures during the study period and within 6 months after the end of the study period.

Exclusion Criteria:

  • Concomitant diseases and medical history:

    1. Have experienced or currently suffer from other malignant tumors within 5 years prior to the first medication use;
    2. Uncontrollable toxic reactions above CTCAE level 1 caused by any previous treatment;
    3. Received significant surgical treatment or significant traumatic injury within 28 days prior to the first medication use;
    4. Long term unhealed wounds or fractures;
    5. Participants who have a history of interstitial lung disease/pneumonia (non infectious) requiring steroid intervention treatment in the past, or currently have interstitial lung disease/pneumonia, or whose screening imaging suggests suspected interstitial lung disease/pneumonia and cannot be ruled out;
    6. An arterial/venous thrombotic event occurred within 6 months prior to the first medication use;
    7. Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
    8. Subjects with any severe and/or uncontrolled diseases. Rheumatoid arthritis with joint function activity graded as Grade IV or requiring wheelchair or bed rest.

  • Tumor related symptoms and treatment:

    1. Participants who have received other anti-tumor drug treatments such as chemotherapy, curative radiotherapy, or immunotherapy within 4 weeks before the first medication, or who are still within the 5 half-lives of the drug (whichever is the shortest); Participants who have previously received local radiotherapy;
    2. Received endocrine therapy or traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug directions within 2 weeks before the first drug use;
    3. Imaging shows that the tumor has invaded important blood vessels, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
    4. Uncontrollable pleural effusion, ascites, and moderate or higher amounts of pericardial effusion that require repeated drainage;
    5. Known presence of cancerous meningitis or clinically active central nervous system metastasis;
    6. Severe bone damage caused by tumor bone metastasis. Suffering from lung diseases that have been determined by the researcher to be unsuitable for participation in this study.
  • Individuals who are known to be allergic to the investigational drug or its excipients, or allergic to humanized monoclonal antibody products.
  • Individuals who have participated in and used other anti-tumor clinical trial drugs within 4 weeks prior to the first medication use.
  • According to the judgment of the researchers, there are situations that seriously endanger the safety of the subjects or affect their completion of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2102 for injection
7.5mg/kg TQB2102, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.
Drug: TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug conjugate (ADC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: Up to 24 months after study start.
The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the RECIST 1.1.
Up to 24 months after study start.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Up to 36 months after study start
From randomization to the time of disease progression or death, whichever occurs first.
Up to 36 months after study start
Duration of disease remission
Time Frame: Up to 24 months after study start
For subjects whose best response is CR or PR , it is defined as from the date when tumor response is first recorded to the date when disease progression is first recorded or the date of death from any cause, whichever occurs first.
Up to 24 months after study start
Disease control rate
Time Frame: Up to 24 months after study start
Percentage of subjects with CR, PR, or stable disease(SD) at 6 weeks or more as determined by RECIST 1.1.
Up to 24 months after study start
Clinical benefit rate
Time Frame: Up to 24 months after study start
The percentage of subjects achieving CR, PR or SD as assessed by the investigator based on the RECIST 1.1.
Up to 24 months after study start
Overall survival
Time Frame: Up to 48 months after study start
From randomization to the time of death from any cause.
Up to 48 months after study start
Incidence of adverse events
Time Frame: Up to 36 months after study start
All adverse medical events (e.g. adverse events, serious adverse event and abnormal laboratory values) that occurred after the subject received the investigational drug.
Up to 36 months after study start
Anti-drug antibody (ADA)
Time Frame: 1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 7 Day1, Cycle 12 Day1, and 30 days after the end of the last infusion. Each cycle is 21 days
Incidence of ADA
1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 7 Day1, Cycle 12 Day1, and 30 days after the end of the last infusion. Each cycle is 21 days
HER2
Time Frame: Up to 24 months after study start
Correlation analysis between HER2 expression level and TQB2102 treatment response
Up to 24 months after study start
circulating tumor DNA (ctDNA)
Time Frame: Up to 24 months after study start
Exploring the genetic variation and dynamic changes of ctDNA, including ctDNA clearance。
Up to 24 months after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2102-II-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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